Is there a right control condition in mHealth trials? A critical view on pain medicine

NPJ Digit Med. 2019 Nov 5;2:107. doi: 10.1038/s41746-019-0184-z. eCollection 2019.

Abstract

When mobile health (mHealth) applications (apps) are investigated, the question of the proper control condition arises. Normally, the randomized controlled trial (RCT) is seen as the gold standard when testing efficacy of clinical interventions. Yet, mHealth apps rarely comprise innovative treatments but rather provide established treatments digitally. The classical RCT utilizing a placebo or waiting group condition may not always be the suitable methodology, since non-treatment is not appropriate if a disease urges treatment and the development of chronic disease needs to be prevented. The present commentary discusses conceivable control conditions in mHealth trials and illustrates their limitations.

Keywords: Clinical trials; Health services.